MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA REVERSE SHOULDER SYSTEM HUMERAL REVERSE METAPHYSIS +9MM/0°; SHOULDER METAPHYSIS

Catalog Number	04.01.0111
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Joint Dislocation (2374)
Date of Event	03/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Batch review performed on 20 march 2024: lot 184050:(b)(4) items manufactured and released on 26-oct-2018.Expiration date: 2023-10-15.No anomalies found related to the problem.Lot 184050a: 17 items have been reworked.No anomalies found related to the problem.Expiration date: 2023-10-15.To date, 16 items of the same lot have been sold with no similar reported event during the period of review.Additional device involved batch review performed on 20 march 2024 reverse shoulder system 04.01.0122 humeral reverse hc liner ø39/+0mm (k170452) lot 2000924: (b)(4) items manufactured and released on 31-march-2020.Expiration date: 2025-03-18.No anomalies found related to the problem.To date, all items of the same lot have been sold with no similar reported event during the period of review.Reverse shoulder system 04.01.0170 glenosphere 39xø24.5 (k170452) lot 2001140: (b)(4) items manufactured and released on 26-may-2020.Expiration date: 2025-05-13.No anomalies found related to the problem.To date, 54 items of the same lot have been sold with no similar reported event during the period of review.
Event or Problem Description
At 3 years and 5 months from the primary, the patient came in reporting instability and the cause is unknown.The surgeon upsized the glenosphere, liner, and metaphysis.The surgery was completed successfully.

• Brand Name: REVERSE SHOULDER SYSTEM HUMERAL REVERSE METAPHYSIS +9MM/0°
• Common Device Name: SHOULDER METAPHYSIS
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: marco giannessi ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 19059643
• Report Number: 3005180920-2024-00206
• Device Sequence Number: 5859853
• Product Code: PHX
• UDI-Device Identifier: 07630040706186
• UDI-Public: 07630040706186
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K170452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/15/2023
• Device Catalogue Number: 04.01.0111
• Device Lot Number: 184050A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2024
• Initial Report FDA Received Date: 04/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/26/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Race: White